# K153044: Sentimag System, Sentimark Magnetic Marker Systerm

- Pathway: 510(k) (Traditional)
- Applicant: Endomagnetics Ltd.,
- Decided: Mar 2, 2016 after 135 days
- Product code: PBY (Temporary Tissue Marker)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K023694 (2003). 21 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120804: Cianna Medical Tissue Marker and Delivery System, Cianna Medical (2013) Summary page 4.

## Most influential descendants
- K163541: Magseed Magnetic Marker System (2017), 12 descendants of its own
- K210600: MOLLI (2021), 5 descendants of its own
- K223107: MOLLI 2 (2023), 4 descendants of its own
- K231579: MOLLI 2 (2023), 3 descendants of its own
- K200734: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit (2021), 2 descendants of its own

## Indications for use
The Endomag Sentimark® Magnetic Marker is intended to be placed percutaneously in the breast to mark temporarily (< 30 days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimag® System) the Endomag Sentimark® Magnetic Marker is located and surgically removed with the target tissue. The Endomag Sentimag® System is intended for the non-imaging detection and localization of the "Endomag Sentimark® Magnetic Marker" that has been implanted in a lumpectomy site intended for surgical removal.

Source page: https://510kreport.com/device/K153044
Methodology: https://510kreport.com/methodology